Retrospective Analysis of the Second Year of Safety Surveillance of the Qdenga® (TAK-003) Vaccine in Private Vaccination Centers, Including a Sub-analysis of Safety in Adults Over 60 Years of Age

The TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals aged 4 years and older, with no upper age limit. Clinical trials demonstrate that Qdenga has a favorable safety and immunogenicity profile in individuals with and without prior dengue infection. However, real-world safety evidence remains limited, particularly in adults over 60 years of age. The aim of this study is to evaluate adverse events following immunization (AEFI) associated with TAK-003 during the second year of implementation and across the combined two-year period at private vaccination centers in the Buenos Aires metropolitan area, with a particular focus on older adults and hypersensitivity reactions.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Dengue Vaccines Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación Vacunar

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All individuals vaccinated with Qdenga at Vacunar centers between November 2, 2024 and November 1, 2025, aged 4 years and older with no upper age limit, in accordance with ANMAT approval (7), and for whom safety data are available through the passive surveillance systems of Vacunar centers.

Exclusion criteria

Reports with insufficient information to characterize the AEFI will be excluded from the analysis.

Treatment and study plan

TAK-003

Biological

Q- Denga vaccine in population >4 years without age limit

Primary outcomes

1- Incidence of adverse events following immunization (AEFI) 2- Overall notification of adverse events following immunization (AEFI)

Time frame: November 2, 2024 - November 1, 2025

Incidence of adverse events following immunization (AEFI): notification rate per 1,000 doses administered during the period November 2, 2024-November 1, 2025. and overall notification rate over the full two year implementation.

Sponsors and collaborators

Lead sponsor

Fundación Vacunar

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Sep 10, 2026
Registry last updated: Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed